Effects of Neuromodulation on Brain Electric Activity of Parkinson's

Status Recruiting

Clinical Trial Summary

Parkinson's disease (PD) is a neurodegenerative and progressive movement disorder, whose population incidence is increasing. It is characterized by motor symptoms such as tremor, stiffness and bradykinesia, and non-motor symptoms, highlighting the executive dysfunction that can be present from the early stages of the disease. These deficits increase the risk of falls and reduce functional independence. Transcranial Direct Current Stimulation (ETCC) can be an attractive rehabilitation option in PD because it is a non-invasive and safe method that can modulate cortical excitability and improve motor and non-motor symptoms. One of the techniques to detect neurophysiological biomarkers associated with changes in the functional health of the brain and the effectiveness of this type of treatment is the analysis of microstates from the electroencephalogram (EEG). So, the objective of the present study is to investigate the effects of different assemblies of multifocal ETCC on the electrical brain activity represented by the EEG microstates and clinical characteristics in patients with PD.

Clinical Trial Description

For this, a randomized, triple-blind clinical trial will be conducted with 60 people with PD, between 40 and 75 years old, regardless of sex, recruited from the reference centers in neurology and physiotherapy in João Pessoa-PB. Participants will be randomized into three groups: Group 1 - ETCC over M1 + CPFDL; Group 2 - ETCC on M1 + APF; Group 3 - ETCC on M1. In each condition an initial baseline assessment (T0) will be performed after 16 treatment sessions (T1) and 30 days after the end of the protocol (Follow-up Assessment - T2). The evaluated outcomes will be: analysis of microstates and spectral analysis of frequencies by EEG; dual task capability with Timed Up and Go (TUG); executive function (Stroop test and verbal fluency test); motor aspects of daily life (MDS UPDRS II). For all analyzes, the statistical software SPSS (SPSS Inc, Chicago IL, USA) for Windows, Version 20.0, will be used and statistical significance considered at 5% (p ≤ 0.05). ;

Study Design

Related Conditions & MeSH terms

Parkinson Disease

Clinical Trial Details

NCT number	NCT04221659
Study type	Interventional
Source	Federal University of Paraíba
Contact	Suellen Andrade
Phone	+55 83 999371471
Email	suellenandrade@gmail.com
Status	Recruiting
Phase	N/A
Start date	December 1, 2019
Completion date	January 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of Neuromodulation on Brain Electric Activity of Parkinson's Disease Patients

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms